THE HAGUE, Netherlands (AP) – The European Union drug watchdog said Thursday that German company BioNTech has requested permission in the 27-country bloc to administer up to six doses of its COVID-19 vaccine from each vial, instead of the five doses. currently approved.
In an email to The Associated Press, the European Medicines Agency said that BioNTech, which has co-developed its vaccine with US drug company Pfizer, has “submitted a request for change” to be reviewed by the Human Medicines Commission. desk “in the shortest possible time…”
It said that if the committee finds that six doses can be consistently extracted from each vial of vaccine, it will recommend changing the authorization that releases the vaccine for use in EU countries.
In a written statement, Pfizer said the vials contain enough vaccine for at least five doses, and the amount remaining may vary depending on the type of needles and syringes used.
“Decisions regarding label updates and / or other temporary approvals regarding dose preparation and administration are up to the local health authorities,” the company said.
German weekly Der Spiegel reported this week for the first time that BioNTech has asked European regulators to change its approval conditions so that doctors can use excess vaccine in the vials to include a sixth dose if possible, instead of disposing of the leftovers. throw after five hours, as currently required.
This could result in hundreds of thousands of extra doses in Germany alone in the first quarter, Spiegel reported.
Regulatory agencies in the United States, Switzerland and the UK already allow up to six doses of 0.3 milliliter each from vials.
“The vaccine has been manufactured in sufficient volume for five doses,” the UK regulator MHRA said in an email. “However, it is normal for some vials to contain a slight excess volume, and in some cases this may extract a full sixth dose.”
However, care must be taken to ensure that a full dose of 0.3 ml can be administered to the individual, he added. “If this cannot be achieved by dilution as recommended, the vial and contents should be discarded after the fifth dose has been extracted.”
However, mixing leftovers from multiple vials is prohibited by all regulators.
German Health Minister Jens Spahn on Wednesday backed the idea of extracting additional doses if possible.
BioNTech deliberately fills the vials with more vaccine than is necessary to ensure that even inexperienced doctors can get at least five doses from them.
Meanwhile, a prominent medical organization in Britain expressed anger that GPs have to rebook tens of thousands of appointments for injections with a second vaccination dose for vulnerable patients following the British government’s decision on Wednesday to extend the period between the required two doses to a maximum of 12 weeks.
“This group of very elderly patients is most at risk of death if they contract COVID-19, which is why GPs are so concerned about them,” said Dr. Richard Vautrey, chairman of the British Medical Association’s committee of GPs. “It is gross and blatantly unfair to tens of thousands of our most at-risk patients to try to reschedule their appointments now.”
Dr. However, Leif-Erik Sander, a senior vaccine researcher at Charite Hospital in Berlin, said the UK strategy makes sense as a temporary one.
“That way we could vaccinate (more people) faster and gain valuable time in the fight against COVID-19,” said Sander.
He said the vaccines made by BioNTech-Pfizer and Moderna have a strong protective effect about 10 days after the first injection. The Moderna vaccine has not yet been approved in the European Union or the UK
“In my opinion, the booster vaccination can be delayed for a while without any problems, without expecting a significant reduction in effectiveness,” he said, pointing out that care should be taken to ensure that everyone eventually gets their second dose. .
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Jordans reported from Bonn, Germany.